FDA device listing
0408-731-000 Flyte Surgicool Toga, XL, Pullover,0408-741-000 Flyte Surgicool Toga, 2XL, Pullover,0408-751-000 Flyte…
FDA device listing 2009308321 · Sotera Health LLC
Key facts
| Proprietary names | 0408-731-000 Flyte Surgicool Toga, XL, Pullover,0408-741-000 Flyte Surgicool Toga, 2XL, Pullover,0408-751-000 Flyte Surgicool Toga, 3XL, Pullover,0408-821-000 Flyte Surgicool Toga, L, Zipper,0408-821-100 Flyte Surgicool Toga, L, Zipper, Peelaway,0408-831-000 Flyte Surgicool Toga, XL, Zipper,0408-831-100 Flyte Surgicool Toga, XL, Zipper, Peelaway,0408-841-000 Flyte Surgicool Toga, 2XL… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | FYA |
| Device names | FYA - Gown, Surgical |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics Costa Rica S.R.L., Sterigenics Germany GmbH, Sterigenics S. de R.L. de C.V., Sterigenics U.S., LLC |
| Establishment registrations | 1721686, 3002807090, 3008328679, 3010432890 |
| FEI numbers | 1721686, 3006003617, 3008328679, 3010432890 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database